Postoperative Adjuvant Therapy of Donafenib for Hepatocel... | NCT06581315

Studies
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

NCT06581315

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

Recruiting

Last Update Posted

Sep 3, 2024Actual

Enrollment

204Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma
Adjuvant Therapy

Interventions

Donafenib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2024Estimated

Primary Completion Date

Aug 30, 2027Estimated

Completion Date

Aug 30, 2032Estimated

First Submitted Date

Aug 30, 2024

First Submission Date that Met QC Criteria

Aug 30, 2024

First Posted Date

Sep 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2024

Last Update Posted Date

Sep 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A (Donafenib)	Experimental	Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.	Drug: Donafenib
Arm B (active surveillance)	No Intervention	Active surveillance of participants.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Donafenib	Drug	Donafenib 100 mg twice daily (BID)	Arm A (Donafenib)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One year recurrence-free survival (RFS) rate	The proportion from randomization to 1 year without recurrence.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Recurrence-Free Survival (RFS )	The time from randomization to disease recurrence, or death from any cause (whichever occurs first).	6 years
Recurrence-Free Survival rate (RFS rate)	The proportion from randomization to 2 years, 3 years or 5 years without recurrence.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
High Risk of recurrence as assessed by tumor characteristics
Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
Child-Pugh Class A statu
ECOG Performance Status of 0 or 1
CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
Expected survival time of no less than 3 months

Exclusion Criteria:

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Evidence of residual or a history of spontaneous tumor rupture
Recurrent HCC
Prior received Liver transplantation
Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
AFP does not return to normal 4 weeks after operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Changzhen Shang, MD	Contact	+86-20-3407 0701		shchzh2@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Changzhen Shang, MD	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510120	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided